Effects of Gelesis200 on Appetite Parameters, Food Intake, and Glycemic Control in Overweight or Obese Prediabetic Subjects: A Sub-Study of LIGHT-UP (MATCH)

This is an interventional treatment trial for Overweight and Obesity Read More

Inclusion Criteria:

• Male or female ambulatory subjects
• Age ≥22 years and 65 years
• Body Mass Index (BMI) ≥27 and ≤40 kilogram (kg)/meter (M)2 with body weight <120 kg
• Prediabetic subjects with FPG ≥100 milligram (mg)/deciliter (dL) and <126 mg/dL [≥5.6 millimole (mmol)/liter (L) and <7.0 mmol/L] at both Screening Visits with HbA1c ≤6.4% [≤46 mmol/mole (mol)] [if only one (1) value is within this range, the other value should not be ≥126 mg/dL (≥7.0 mmol/L) and HbA1c should be ≥5.7% (≥39 mmol/mol) and ≤6.4% (≤46 mmol/mol)], untreated diabetic subjects with FPG ≤ 200 mg/dL (≤ 11.2 mmol/L) at both Screening Visits and either FPG ≥126 mg/dL (≥7.0 mmol/L) at both Screening Visits or HbA1c ≥6.5% (≥48 mmol/mol) if FPG is <126 mg/dL (<7.0 mmol/L) at one (1) or both Screening Visits, or metformin-treated diabetic subjects with FPG ≥70 mg/dL and ≤270 mg/dL (≥3.9 mmol/L and ≤15.1 mmol/L) at both Screening Visits
• Fasting serum insulin <24 microunit ([Symbol]U)/milliliter (mL) at both Screening Visits in prediabetic subjects
• Ability to follow verbal and written instructions
• Consent obtained via signed ICF

Exclusion Criteria:

• Pregnancy [or positive serum or urine pregnancy test(s) in females of childbearing potential]
• Absence of medically approved contraception in females of childbearing potential [exempli gratia (e.g.), hysterectomy, oral contraceptive medications, intrauterine device combined with a barrier method, two (2) combined barrier methods such as diaphragm and condom or spermicide, or condom and spermicide; bilateral tubal ligation and vasectomy are acceptable contraceptive methods when combined with another single method from above]
• History of allergic reaction to carboxymethylcellulose (CMC), citric acid, maltodextrin, gelatin, or titanium dioxide
• Participation in a weight loss study within the past twelve (12) months
• Administration of Gelesis100 or Gelesis200 in a previous study
• Administration of investigational products within one (1) month prior to Screening Visit
• Smoking cessation within six (6) months prior to Screening Visit or considering smoking cessation during the study
• Anticipated surgical intervention during the study period
• Known Type 1 Diabetes
• History of eating disorders including binge eating (except for mild binge eating) or emesis ≥2/week from any cause
• Weight change >3% within three (3) months prior to and during the Screening period
• Supine systolic blood pressure (SBP) >160 millimeters of mercury (mmHg) and/or supine diastolic blood pressure (DBP) >95 mmHg
• Angina, coronary bypass, or myocardial infarction within six (6) months prior to Screening Visit
• History of swallowing disorders
• Esophageal anatomic abnormalities (e.g., webs, diverticuli, rings)
• History of gastroesophageal reflux disease
• History of gastric or duodenal ulcer
• History of gastroparesis (e.g., chronic nausea, vomiting ≥2 occurrences per week, heartburn, etc.)
• History of gastric bypass or any other gastric surgery
• History of small bowel resection (except if related to appendectomy)
• History of intestinal stricture (e.g., Crohn's disease)
• History of intestinal obstruction or high risk of intestinal obstruction, including suspected small bowel adhesions
• History of abdominal radiation treatment
• History of pancreatitis within the past 12 months
• History of malabsorption
• Laxative users, except those on stable doses within one (1) month prior to Screening Visit
• History of hepatitis B or C
• History of human immunodeficiency virus (HIV)
• History of cancer within the past five (5) years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer)
• Any other clinically significant disease interfering with the assessments of Gelesis200 (e.g., disease requiring corrective treatment, potentially leading to study discontinuation)
• Abnormal serum thyroid-stimulating hormone (TSH)
• HbA1c >8.5% (>69 mmol/mol)

• Serum low-density lipoprotein (LDL) cholesterol

  -≥160 mg/dL (≥4.15 mmol/L)

• Serum triglycerides ≥350 mg/dL (≥3.96 mmol/L)
• Positive test for drugs of abuse in the urine
• Any relevant biochemical abnormality interfering with the assessments of Gelesis200
• Anti-obesity medications (including herbal preparations) within one (1) month prior to
• Screening Visit
• Systemic corticosteroids within one (1) month prior to Screening Visit
• Thyroid hormones or preparations within one (1) month prior to Screening Visit [except stable dose of replacement therapy for at least two (2) months]
• TSH suppression therapy for thyroid cancer
• Estrogen within one (1) month prior to Screening Visit [except stable dose of replacement therapy or contraceptives for at least one (1) month]
• Any other medication known to cause weight loss or weight gain within one (1) month prior to Screening Visit
• Antidiabetic medications within one (1) month prior to Screening Visit [except stable doses of metformin for at least one (1) month in subjects with Type 2 Diabetes]
• Change in medications treating hypertension within one (1) month prior to Screening Visit
• Change in medications treating dyslipidemia within one (1) month prior to Screening Visit
• Anticipated requirement for use of prohibited concomitant medications
• Any other condition that, in the opinion of the Investigator or Sponsor, would interfere with the subject's ability to participate in the study